FDA points advertising and marketing denial for six,500 flavored e-cigarettes
Might 12 (Reuters) – The U.S. Meals and Drug Administration (FDA) on Friday issued advertising and marketing denial orders to 10 corporations which collectively manufacture and market about 6,500 flavored e-liquid and e-cigarette merchandise.
The well being regulator mentioned these corporations can’t market or distribute the merchandise within the U.S. and retailers who promote them threat FDA enforcement motion.
Any firm that desires to legally market a brand new tobacco product in america should obtain a written advertising and marketing order from FDA. But when the well being regulator deems it unfit for public well being, it points a advertising and marketing denial order.
The FDA named eight of those corporations that obtained the denial orders, which embrace Imperial Vapors LLC, Savage Enterprises and Massive Time Vapes, amongst others.
Nevertheless, the FDA mentioned it was not disclosing the names of the opposite two corporations to guard potential confidential industrial info.
The FDA added the premarket tobacco product functions (PMTAs) submitted for a wide range of flavored e-cigarette merchandise didn’t present ample proof to point out that allowing the advertising and marketing of those merchandise could be applicable for public well being.
A few of the flavors denied by the well being regulator embrace Citrus, Strawberry Cheesecake, Cool Mint and Menthol.
Nevertheless, Altria Group Inc’s (MO.N) NJOY has six e-cigarette merchandise which have obtained full approval from the FDA.
Juul, one other e-cigarette maker wherein Altria was a former investor, remains to be in search of approval for its merchandise. The FDA final yr briefly banned Juul’s merchandise however put it on maintain and agreed to rethink after the corporate appealed.
Reporting by Ananya Mariam Rajesh in Bengaluru; Enhancing by Krishna Chandra Eluri
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